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Modification to improve efficiency of sampling schedules for BA/BE testing of FDC anti-tuberculosis drugs.

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      Abstract

      The assessment of rifampicin (RMP) containing fixed-dose combination (FDC) formulations using in vivo bioequivalence testing is widely accepted. It would be advantageous for both the drug regulatory authorities and drug manufacturers, for optimum minimum blood testing time intervals that encompass all anti-tuberculosis active constituents in the FDC to be established.

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      Affiliations
      [1 ] Division of Clinical Pharmacology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Rondebosch, South Africa. ggabriel@uctgsh1.uct.ac.za
      Journal
      Int. J. Tuberc. Lung Dis.
      The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease
      1027-3719
      1027-3719
      Feb 2007
      : 11
      : 2
      17263289

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